Sample collection device

ABSTRACT

Provided herein is technology relating to collecting and preparing samples. For example, the technology relates particularly, but not exclusively, to devices, systems, and kits that allow a subject to collect and prepare a sample for analysis.

The present application is a continuation of U.S. patent applicationSer. No. 13/587,552, filed Aug. 16, 2012, and now allowed, which claimspriority to U.S. Provisional Application Ser. No. 61/524,208, filed Aug.16, 2011, each of which is incorporated herein by reference.

FIELD OF INVENTION

Provided herein is technology relating to collecting and preparingsamples. For example, the technology relates particularly, but notexclusively, to devices, systems, and kits that allow for the collectionand preparation of a fecal sample for analysis.

BACKGROUND

Over 100,000 persons per year in the United States are afflicted with acancer of the colon and rectum. When the number of colon and rectalcancers occurring each year is combined with the number of cancersoccurring in other digestive organs, including the esophagus andstomach, cancers of the digestive system account for more occurrences ofcancer than any other single form of the disease. Contrary to many otherforms of cancer, early diagnosis and treatment of digestive tract cancerresults in a cure rate of 80% to 90%. If, however, the disease is notdetected until its later stages, the cure rate drops significantly.Thus, early detection of the disease is important for the successfultreatment of digestive tract cancer.

Most cancers of the digestive tract bleed to a certain extent. Thisblood is deposited on and in fecal matter excreted from the digestivesystem. The presence of blood in fecal matter is not normally detected,however, until gross bleeding occurs—that is, until the blood is visibleto the naked eye. Gross bleeding, however, is symptomatic of advancedcancers.

Early-stage digestive tract cancers, including pre-cancerous polyps,also tend to bleed, which produces occult (hidden) blood in the fecalmatter. Other pathological conditions, such as Crohn's disease anddiverticulitis, also produce occult blood in the fecal matter.Accordingly, test equipment and test procedures have been developed foruse by physicians in testing for the presence of occult blood in fecalmatter as an aid for diagnosing these and other medical conditions.

For example, a commonly used test for screening for colorectal cancer isa fecal occult blood test, which tests for the presence of hemoglobin infeces. The presence of hemoglobin in feces is an indicator of intestinalbleeding, which is frequently associated with colorectal cancer. Whensuch fecal blood is detected, a patient can be referred for furthermedical testing.

Fecal immunochemical testing (FIT) is one type of assay used to detecthemoglobin indicative of fecal occult blood. FIT uses an antibodyspecific to the human globin protein of hemoglobin to measure the amountof blood in feces. To perform FIT on feces one first obtains a definedquantity of feces and suspend the sampled feces in a suitable liquid toprepare a feces suspension appropriate for testing. There is a need fora device that provides for an easy acquisition of a defined quantity offeces by a user and for the preparation and testing of a portion of thesample by a human or automated tester.

SUMMARY OF THE INVENTION

Accordingly, provided herein is a device for obtaining a fecal sampleand preparing a suspension of the feces suitable for analysis, e.g.,FIT. For example, in some embodiments, the technology comprises a devicefor collecting a sample, the device comprising a sample collectionchamber bounded on a distal end by a penetrable seal and bounded on aproximal end by a septum, the septum comprising an aperture; a samplingrod adapted to fit through and seal the aperture, the sampling rodcomprising a proximal portion having a proximal end, a distal portionhaving a distal end, an angled tip at the distal end, and at least onemetering ridge near the distal end; and a solution comprisingapproximately 20 mM Tris (pH 7.4), 10% bovine serum albumen, 0.10%Tween-20, 0.095% sodium azide, 140 mM sodium chloride, 10 mM EDTA, and15 μg/ml gentamicin. The metering ridge is designed for two primarypurposes: first, the metering ridge provides a surface that facilitatesthe efficient acquisition of a fecal sample from a stool; second, thegeometry of the metering ridge provides for the acquisition of a definedquantity (e.g., a volume or mass) of feces for the analysis. Embodimentsof the metering ridges have particular designs and geometries that areadvantageous for use of the sampling rod. For example, in someembodiments the metering ridge comprises a frustum of a cone, e.g., aright circular cone. Some embodiments provide that an axis of thefrustum is coaxial with a longitudinal axis of the sampling rod and abase of the frustum faces the proximal end of the sampling rod.Moreover, in some embodiments the radius of the base of the frustum isapproximately the same as the radius of the proximal end of the samplingrod. Some embodiments provide a series of metering ridges arranged in a“sawtooth” or “fish scale” pattern, e.g., in some embodiments the devicecomprises a plurality of stacked coaxial frusta to form a plurality ofmetering ridges.

During the development of particular embodiments of the technology, itwas discovered that particular characteristics of the sampling rod areadvantageous for use of the sampling rod. For example, in someembodiments the sampling rod is flexible, e.g., to allow it to bend. Insome embodiments a cap is attached to the proximal end of the samplingrod, e.g., to seal the device, and in some embodiments a distal portionof the sampling rod has a radius approximately the same as the radius ofthe aperture and a proximal portion of the sampling rod has a radiuslarger than the radius of the aperture, e.g., to seal the aperture. Thatis, in some embodiments a junction of the distal portion with theproximal portion forms a stopper that seals the aperture when the distalportion is fully inserted through the aperture.

In some embodiments the device is designed to provide a metered samplefor analysis. Specifically, after capturing a sample on the meteringridge, inserting the sampling rod through the aperture removes excesssample from the sampling rod and leaves a metered sample within thedepressions of the metering ridge. The device is designed to provideaccess to the suspension of feces so that a portion is taken for testingby a human or an automated tester. Accordingly, in some embodiments thepenetrable seal is penetrable by a pipette tip or needle. During thedesign of some embodiments of the device, it was discovered that aninserted pipette tip or needle sometimes collided with the sampling rodin the sample collection chamber. Such collisions may occur when a humanis using a pipette or needle to obtain a portion of the suspension orwhen withdrawing the sample is automated, for example, by usingrobotics, and can result in errors in sampling or damage to samplingdevices. As such, in some embodiments, the angled tip of the samplingrod deflects a pipette tip or needle that penetrates the penetrableseal. In some embodiments, the sampling rod is flexible and thus is ableto move, e.g., to flex or bend in response to force, when a pipette tipor syringe needle collides with it.

The device is not limited in the types of samples that are obtained andprepared. Thus, while in some embodiments the device is used to samplefeces, the sample in some embodiments is, for example, environmentalmatter (e.g., mud), biological matter (e.g., food), and industrialmatter (e.g., sludge). Such examples are meant to be merely illustrativeand not limiting and many other materials are suitable for sampling withthe device.

The geometrical design of the device may take many forms. For example,in some embodiments the body is tubular, though it may also be square,rectangular, triangular, elliptical, or any other shape suitable toprovide the required functions, e.g., manipulation of the device by auser and acquisition of a sample. Furthermore, the sampling rod mayassume many forms. For example, in some embodiments the sampling rod iscylindrical.

In one aspect the device is designed for a user to provide a sample inone end and for a human or machine (e.g., a robot) tester to acquire aportion of the fecal suspension at the other end. Thus, embodimentsprovide devices comprising a penetrable seal through which a portion ofthe suspension is obtained. Some embodiments provide that the seal ismade from foil. However, other materials are appropriate for the deviceprovided the material seals the sample collection chamber while alsobeing penetrable (e.g., by a pipette tip or by a syringe needle) suchthat a human or machine obtains a portion of the contents sealed withinthe sample collection chamber (e.g., a suspension of fecal matter in asolution). Some non-limiting examples of materials provided in variousembodiments include paper, rubber, wax, and plastic.

Embodiments of the device have various physical characteristics withrespect to materials and/or design. For example, embodiments of thedevice are made from, for example, polypropylene, polyethylene,polystyrene, and polytetrafluoroethylene. Moreover, in some embodimentsthe sample collection chamber has a volume of approximately 1-2milliliters, in some embodiments the metering ridge provides a fecalsample of approximately 20 milligrams.

The devices provided herein find use in systems and kits for providing afecal sample for testing. For example, some embodiments of thetechnology provided herein are systems for collecting a sample. Thesesystems comprise a chamber functionality for holding a samplere-suspension solution, a penetrable seal functionality for sealing thechamber on one end and allowing access to the chamber by penetrating theseal functionality, a sampling functionality for contacting the sampleand acquiring a portion of the sample, and a metering functionality forproviding into the chamber functionality a defined volume of theacquired portion of the sample. Furthermore, the technology provideskits, embodiments of which comprise embodiments of the devices providedherein and an instruction for use. Moreover, in some embodiments thekits comprise a package in which to mail the collected sample.

Additional embodiments will be apparent to persons skilled in therelevant art based on the teachings contained herein.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other features, aspects, and advantages of the presenttechnology will become better understood with regard to the followingdrawings:

FIG. 1 is a side view of an embodiment of the device provided herein.

FIG. 2 is a side section view of an embodiment of the device providedherein, comprising a body (1) and a cap (12), the body (1) comprisingproximal chamber (11) and a distal sample collection chamber (10). Thedistal sample collection chamber (10) is bounded on a distal end by apenetrable seal (2) on a sealing surface (13) on the body (1), and isbounded on a proximal end by a septum (3), the septum comprising anaperture (4). The cap (12) is affixed to the proximal end of a samplingrod (5) adapted to fit through and seal the aperture (4). The samplingrod (5) comprises a proximal portion (6), and a distal portion (7)having an angled tip (8) at the distal end and at least one meteringridge (9) near the distal end.

FIG. 3 is an isometric section view of an embodiment of the deviceprovided herein.

FIG. 4 is an exploded view of an embodiment of the device providedherein.

FIG. 5 is in a side view of an embodiment of the body component.

FIG. 6 is a side section view of an embodiment of the body component.

FIG. 7 is an isometric section view of an embodiment of the bodycomponent.

FIG. 8 is a side view of an embodiment of the sampling rod component.

FIG. 9 is a side section view of an embodiment of the sampling rodcomponent.

FIG. 10 is an isometric section view of an embodiment of the samplingrod component.

FIG. 11 is an isometric view of an embodiment of the sampling rodcomponent.

DETAILED DESCRIPTION

Provided herein is technology for acquiring a sample (e.g., a fecalsample) and preparing a suspension of the sample for analysis (e.g., afecal immunochemical test). The device comprises two ends—one (proximal)end that is accessed by the user who acquires the sample and introducesit into the device for preservation and storage and the other (distal)end that is accessed by a human or automated tester for removing aportion of the resuspended sample for analysis. The features andcomponents described herein combine to provide such functionality in asimple device that produces preserved and stable metered fecal samplesfor analysis (e.g., by FIT).

Definitions

To facilitate an understanding of the present technology, a number ofterms and phrases are defined below. Additional definitions are setforth throughout the detailed description.

As used herein, “a” or “an” or “the” can mean one or more than one. Forexample, “a” widget can mean one widget or a plurality of widgets.

As used herein, a “penetrable seal” hermetically closes an opening of achamber or enclosed space while the component is intact and is capableof being pierced or breached (e.g., by a needle or a pipette tip) toallow access to the contents sealed inside.

As used herein, the term “metered” means having a reasonablyreproducible measured quantity.

Embodiments of the Technology

Although the disclosure herein refers to certain illustratedembodiments, it is to be understood that these embodiments are presentedby way of example and not by way of limitation.

As shown by FIGS. 1-11, the device comprises as principal components asampling rod, a body comprising a septum and a penetrable seal, and asolution. Embodiments of the device, particularly in reference to theinteractions of these and other components, are described below.

1 Sampling Rod

The device comprises as a first component a sampling rod (5). Asillustrated, e.g., in FIG. 2, the sampling rod (5) comprises a distalportion (7) and a proximal portion (6). In some embodiments the samplingrod is approximately 2.5 inches long. In certain preferred embodiments,the sampling rod is substantially circular in cross section for most ofits length.

The proximal portion (6) of the sampling rod (5) is adapted formanipulation by a user and the distal portion (7) is adapted to acquirea metered sample. In some embodiments, a cap (12) is attached to theproximal end. In preferred embodiments, the cap (12) is adapted to matewith and close the proximal end of the body (1) (see below), forexample, by mated threads on the cap (12) and body (1), by a snapclosure, by a friction seal, or by other closures by which a capsecurely closes a vessel to seal contents inside the vessel. In someembodiments, mated threads on the cap (12) and body (1) provide forsecuring the sampling rod (5) with a half-turn screw fit to the body(1). In some embodiments, the cap (12) comprises textured features thatfacilitate gripping and manipulating the sampling rod (5) by the user.

One or more metering ridges (9) is/are located near the tip (distal end)of the distal portion (7) of the sampling rod (5) (see FIGS. 2, 4, 5,and 8). In certain embodiments, each metering ridge is shaped like thefrustum of a cone (e.g., a right circular cone, truncated by a planeparallel to the base). In preferred embodiments, the frustum has itsbase facing toward the proximal end of the sampling rod (5), and has itsaxis aligned with the longitudinal axis of the sampling rod. As is seenin the embodiments shown in the figures (e.g., FIG. 8), in someembodiments a series of axially aligned frusta are joined in someembodiments to make notched depressions in the distal end of thesampling rod (e.g., to form a serrated, saw tooth, or fish scalestructure). In preferred configurations, the bases of the frusta haveradii approximately the same as the radius of the distal portion of thesampling rod; thus, the radii of the tops of the frusta are smaller thanthe radius of the sampling rod.

The notched depressions of the metering ridges provide a structurewithin which to acquire a metered sample (e.g., a sample ofapproximately 20 milligrams). In use, rubbing and/or scraping the areacomprising the metering ridges (9) on the stool to be sampled captures amass of stool that covers the metering ridges (9) on the distal portionof the sampling rod. Furthermore, the metering ridges provide aneffective way to collect a reasonably reproducible and defined volumeand/or mass (e.g., approximately 20 milligrams) of feces for the sample.In particular, feces captured in the notched depressions remainassociated with the sampling rod when the sampling rod is passed througha hole or aperture that is approximately the same radial size as theradius of the distal portion (7) of the sampling rod (5) (e.g., theaperture of the body septum as described below). The metering ridgescomprise notched depressions having a defined volume for collecting asample of a defined mass. Thus, when excess feces that is not present inthe space defined by the notched depressions is scraped or rubbed fromthe sampling rod, e.g., by passage through an aperture, the fecesremaining in the notched depressions has a volume defined by the sizeand shape of the notched depressions.

The sampling rod (5) is adapted to be inserted into the body (1), and,in particular, the sampling rod (5) is designed to fit through the bodyseptum aperture, (a feature described in more detail below). Moreover,when inserted into the body (1), the sampling rod (5) is designed toseal the aperture (4) at the end of travel and thus seal the body samplecollection chamber (10) (see below). In some embodiments, the device isdesigned to provide a seal at the aperture (4) that holds a minimum of30 psi when internally pressurized with air. In particular, the samplingrod (5) comprises a proximal portion (6) and a distal portion (7). Incertain preferred embodiments, the distal portion (7) has a radius thatis smaller than the radius of the proximal portion (6) (see, e.g., theembodiment shown in FIGS. 2 and 8). Furthermore, in relation to theaperture (4) in the body septum (3), the radius of the distal portion(7) of the sampling rod (5) is smaller than the radius of the aperture(4) (e.g., very slightly smaller, such that excess feces is removed fromthe sampling rod (5) when the distal portion (7) passes through theaperture (4)), and the radius of the proximal portion (6) is larger thanthe radius of the aperture (4). Consequently, the junction of theproximal and distal portions of the sampling rod (5) forms a plug orstopper that seals the aperture (4) (and thus the sample collectionchamber (10)) when the sampling rod (5) is substantially fully insertedinto the body at the end of travel. In some embodiments, tightening thecap (12) onto the body (1) (e.g., by screwing) further secures the seal.

In some embodiments, the distal tip (8) of the sampling rod is angled orbeveled (see, e.g., (8) in the embodiments shown in FIGS. 2 and 8). Wheninserting a pipette tip or syringe needle into the distal end of thebody (1) to withdraw an aliquot of the feces suspension (as describedbelow), the tip or needle may sometimes collide with the sampling rodand consequently interrupt or otherwise compromise the withdrawal of theproper amount and/or damage the apparatus or machine used to withdrawthe sample. While this is problematic for a human operator, a trainedhuman can realize what has occurred and makes another attempt atwithdrawing the proper volume as an aliquot for assay. However, in anautomated setting wherein an autonomous robot or semi-autonomous systemretrieves the aliquot, collision with the sampling rod may damage themachine and/or cause improper sampling. Consequently, an improper volumewill be tested and produce an inaccurate and potentially misleadingresult (e.g., a false negative or false positive result). To minimize oreliminate such episodes, embodiments of the technology provide asampling rod (5) with an angled tip (8) that, when inserted into thebody (1) after acquiring a fecal sample, deflects collisions with aninserted pipette tip, syringe needle, or other implement insertedthrough the penetrable seal (2) e.g., to withdraw an aliquot of thefecal suspension. Moreover, in some embodiments, the sampling rod ismade from a material that is flexible, so that it flexes or bends out ofthe way when a collision occurs. Deflection and/or flexing minimizes oreliminates the mechanical stress and trauma to the sampler and/orimproper sampling that is associated with collisions and thus aids inmaximizing the reproducibility of sampling and testing.

2 Body

The device comprises as another component a body (1). The body comprisesa proximal chamber (11) and a distal sample collection chamber (10)(see, e.g., FIG. 2). The two chambers are separated by a septum (3), andthe septum comprises an aperture (e.g., a hole, (4)) near its centerthat is just slightly large enough to allow passage of the distalportion (7) of the sampling rod (5) through it (see FIGS. 2 and 3). Thelong axis of the body has a length appropriate to contain the entiretyof the sampling rod when the sampling rod is fully inserted into thebody. In some embodiments, the outer diameter of the body isapproximately 14 millimeters. When the sampling rod (5) is substantiallyfully inserted into the body (1) (e.g., at its end of travel into thebody), the metering ridge (9) (and substantially all the acquired samplepresent within the notched depressions of the metering ridge) is locatedcompletely within the sample collection chamber (10) and thus is exposedthere to any solution contained therein (see below). In preferredembodiments, the device is designed such that the sample containedwithin the metering ridge (9) contacts the solution in the samplecollection compartment regardless of the orientation of the device.

The sample collection chamber (10) is bounded laterally by the body walland on the proximal and distal ends by the septum (3) and by apenetrable seal (2) (see below, and FIG. 2, e.g.), respectively. In someembodiments, the proximal end of the body (1) is adapted to mate with acap (12) attached to the proximal end of the sampling rod (5), forexample, by means of mated threads on the cap and body (e.g., forsecuring the cap and sampling rod to the body with a half-turn screw), asnap closure, a friction seal, or other features by which a cap securelycloses a vessel. See, e.g., body (1) and cap (12) in FIG. 2.

The body (1) is open on the distal end, e.g., the body comprises a holeon the distal end. The body (1) comprises a sealing surface (13) that isadapted to accept a penetrable seal on the distal end to cover the hole.See, e.g., sealing surface (13) in FIGS. 2, 3, and 6. In someembodiments the penetrable seal (2) is recessed. In certain preferredembodiments, the penetrable seal (2) is recessed approximately 0.125inches with respect to the distal end of the body. In some embodimentsthe distal end of the body is adapted to accept a removable cover orcap, e.g., a pop-off cap, to protect the penetrable seal. In preferredembodiments, the diameter of the hole in the distal end of the body (1)is smaller than the width of the distal end of the body so that a ringof material is present on the distal end surrounding the hole, providinga surface on which to apply a penetrable seal (2). See, e.g., thesealing surface (13) in FIGS. 2 and 7. By affixing the penetrable seal(2) to the distal end of the body over the hole, the penetrable seal (2)hermetically closes the distal end of the body.

The sample collection chamber (e.g., sample collection chamber (10) inFIGS. 2 and 3) is adapted to hold a solution (e.g., the solutiondescribed below). In some embodiments, the sample collection chamber isadapted to hold a solution having a volume of approximately 2milliliters. In some embodiments, when the sample collection chambercontains a solution, sample introduced into the chamber on the samplingrod is covered with the solution regardless of the orientation of thedevice. Furthermore, in certain preferred embodiments, when the samplecollection chamber contains a solution, the sample collection chamberalso holds a volume of air that allows for mixing of the sample with thesolution. When the penetrable seal is secured to the distal end and thesampling rod is substantially fully inserted into the body to seal theaperture (e.g., at the end of travel for the sampling rod into thebody), the solution is contained within the sample collection chambersuch that it will not leak from the sample collection chamber. In someembodiments, the seal formed at the aperture holds a minimum of 30 psiwhen the device is internally pressurized with air. In some embodimentsof the technology provided herein (e.g., embodiments of kits), thedevice is supplied to the end user in this type of a configuration(e.g., preloaded with solution and sealed by the sampling rod andpenetrable seal).

3 Penetrable Seal

A third feature of the device is a penetrable seal. In preferredembodiments, the penetrable seal (2) is affixed to the distal end of thebody to cover the hole on that end, thus sealing the sample collectionchamber (10) on that end (and thus preventing the escape of any solutionand/or sample that is contained inside). See, e.g., penetrable seal (2)in FIGS. 2, 3, and 4. The penetrable seal (2) is affixed to the body byany suitable means that adequately seals the distal end of the body,e.g., by an adhesive, crimping, friction, physical incorporation intothe body when the body is molded, etc. For example, in some embodimentsthe penetrable seal is affixed to the body such that it provides a sealof the distal end that holds a minimum of 30 psi when the device isinternally pressurized with air.

Furthermore, the penetrable seal is made from a material that can bepenetrated, e.g., by a syringe needle or a pipette tip, to allow accessto the sample collection chamber by a human user or an automated orsemi-automated robot or other machine. Materials that are appropriatefor the penetrable seal include, but are not limited to, foil, paper,rubber, plastic, and wax. The penetrable seal is made from a materialthat is chemically and biochemically compatible with the solution andsamples that contact the device. The penetrable seal is strong enough tocontain a solution securely (e.g., without leaking (e.g., the seal holdsa pressure of 30 psi when internally pressurized with air)) within thesample collection space, while also being penetrable upon application ofa low to moderate amount of force by a needle or pipette tip (e.g., a1-milliliter pipette tip) pressed against the penetrable seal by a user,machine, or robot. For example, in some embodiments the penetrable sealcomprises a laminated foil comprising a foil layer of approximately0.001 inches and a polyester layer of approximately 0.005 inches. Such afoil product is available from commercial vendors (e.g., Hi-TechProducts). In some embodiments, other products are used that aresuitable to meet the shelf life and sealing requirements.

4 Solution

The device comprises a solution in the sample collection chamber. Incertain embodiments, the solution comprises Tris buffer, bovine serumalbumin, Tween-20, sodium azide, sodium chloride, EDTA, and gentamicin.In preferred embodiments, the solution comprises the followingcomponents approximately in the indicated amounts and/or concentrations:

-   -   20 mM Tris buffer (pH 7.4)    -   10% bovine serum albumen    -   0.10% Tween-20    -   0.095% sodium azide    -   140 mM sodium chloride    -   10 mM EDTA    -   15 μg/ml gentamicin

The solution comprises components to break up, solubilize, and/orsuspend the sample such that withdrawal of a portion provides an aliquotsuitable for analysis. In addition, the solution comprises components tostabilize, preserve, and/or protect the resulting suspension so that theanalytes to be tested (e.g., globin) do not degrade or become damagedbetween the time the sample is acquired and the time the sample istested. The solution thus helps to ensure that the analysis of thesample (e.g., a FIT) accurately reflects the analytes (e.g., globin)present in the sample when the sample was acquired.

5 Materials

The body (1), sampling rod (5), and cap (12) are made from a materialthat provides structural soundness to the device and that is chemicallyand biochemically compatible with the solution and samples that contactthe device. Embodiments of the device are made from plastics such as,e.g., polypropylene, polyethylene, polystyrene, andpolytetrafluoroethylene. The sampling rod (5) is made from a materialthat provides sufficient strength to the rod for collecting fromrelatively rigid samples. For example, in some embodiments the samplingrod is made from an opaque polypropylene and in some embodiments thesampling rod is made from a filled polypropylene. In some embodiments,the sampling rod is flexible and is thus made from a material thatprovides the appropriate flexibility, e.g., a flexible polypropylene. Insome embodiments, the cap (12) and the body (5) are made of the samematerial. Moreover, in some embodiments the body is made from atransparent polypropylene. Different materials may be suitable fordifferent applications and sample types, and, in some embodiments, thebody and sampling rod are made from the same material and in someembodiments the body and sampling rod are made from different materials.In some embodiments, the materials and composition of the solution arechosen to provide a shelf-life for the device of approximately 2 years.

6 Use of the Device

The device is designed to provide an easy way to collect and producefecal samples for analysis such as FIT. Accordingly, it is designed foruse by both the sample taker and the sample tester. The sample taker maybe, in some uses of the device, a person who does not have medical orclinical training, and thus the device is easy to use for such lay usersin acquiring the sample. Thus, in some embodiments the body is composedof opaque material, or is covered, e.g., with a label, such that theinterior components (e.g., the proximal and distal chambers, the septum,and the inserted sampling rod) are substantially blocked from view of auser, e.g., to avoid confusion regarding the proper use of the device.

At the same time, the device is designed within the appropriatetolerances and with a design that allows for precise and accurateanalysis of the sample by a human or machine tester. Generally, thedevice will be provided to the sample provider in an assembledform—e.g., the sample collection chamber is filled with a volume ofsolution, the distal end of the body is sealed with the penetrable seal,and the sampling rod is fully inserted into the body such that theaperture is sealed.

Upon producing a stool, the sample provider removes the sampling rod (5)from the body (1) and scrapes or spears the stool with the sampling rod(5) to cover with stool the distal portion (7) of the sampling rod (5)comprising the metering ridge (9). The sampling rod (5) is then placedback into the body (1) by inserting the sampling rod (5) through theaperture (4) and securing the cap (12) to the body (1) (e.g., byscrewing it onto the body by means of mated threads). When the samplingrod (5) is inserted through the aperture (4) in the body (1), stool notpresent in the notched depressions of the metering ridge (9) (e.g.,excess stool) is rubbed and/or scraped from the sampling rod such thatit remains in the proximal chamber (11) and outside the samplecollection chamber (10). Consequently, only the feces associated withthe metering ridge (9) is introduced into the sample collection chamber(10) and the solution present therein. The solution then acts to breakup, solubilize, and/or suspend the sample. In addition, the solutioncomprises components to stabilize, preserve, and/or protect thesuspension. The user then returns the device to a laboratory, clinic, orother location for analysis. In some embodiments, the device is designedto be appropriate for return by mail.

Next, the testing facility retrieves a portion of the feces suspensionfor analysis (e.g., by FIT). A user or machine penetrates the penetrableseal (2) (e.g., by a syringe needle or a pipette tip) to withdraw analiquot of the suspension. The device is designed for manipulation by ahuman tester, an autonomous machine or robot, and/or a semi-autonomousmachine, as appropriate for the analysis. After the required aliquot ofthe suspension is withdrawn, the device and remaining fecal samplesuspension may then by discarded as appropriate.

All publications and patents mentioned in the above specification areherein incorporated by reference in their entirety for all purposes.Various modifications and variations of the described compositions,methods, and uses of the technology will be apparent to those skilled inthe art without departing from the scope and spirit of the technology asdescribed. Although the technology has been described in connection withspecific exemplary embodiments, it should be understood that theinvention as claimed should not be unduly limited to such specificembodiments. Indeed, various modifications of the described modes forcarrying out the invention that are obvious to those skilled inpharmacology, biochemistry, medical science, or related fields areintended to be within the scope of the following claims.

We claim:
 1. A device for collecting and preserving a sample, the devicecomprising: a) a body comprising a sample collection chamber bounded ona distal end by a penetrable seal and bounded on a proximal end by aseptum comprising an aperture, said penetrable seal being penetrable bya pipette tip or needle; b) a flexible sampling rod comprising aproximal portion and a distal portion, said sampling rod adapted to fitthrough and seal said aperture when said distal portion is in saidsample collection chamber, wherein said distal portion comprises: i) anasymmetrical beveled tip at a distal end, said beveled tip having anapex at the circumference of the flexible sampling rod and configured tobend the flexible sampling rod away from collisions and/or to deflectcollisions with an inserted pipette tip or needle; and ii) a pluralityof metering ridges; and c) a solution in said sample collection chamberfor preserving a suspended sample.
 2. The device of claim 1 wherein saidsolution comprises Tris buffer, bovine serum albumen, polysorbate 20,sodium azide, sodium chloride, ethylenediaminetetraacetic acid, andgentamicin.
 3. The device of claim 1 comprising a plurality of stackedcoaxial frusta cones to form said plurality of metering ridges.
 4. Thedevice of claim 1 wherein a cap is attached to said proximal end of saidsampling rod, wherein said cap is configured to engage a proximal end ofsaid body.
 5. The device of claim 4 wherein said cap and said proximalend of said body have mated threads for securing said cap to said body.6. The device of claim 1 wherein said aperture has a radius, and whereinsaid distal portion of said sampling rod has a radius approximately thesame as said radius of said aperture and said proximal portion of saidsampling rod has a radius larger than said radius of said aperture. 7.The device of claim 6 wherein a junction between said distal portion ofsaid sampling rod and said proximal portion of said sampling rod forms astopper that seals said aperture when said distal portion of saidsampling rod is fully inserted through said aperture.
 8. The device ofclaim 7 wherein said aperture when sealed is configured to hold 30 psiwhen the device is internally pressurized with air.
 9. The device ofclaim 1 wherein said sampling rod and said aperture are configured suchthat insertion of said sampling rod through the aperture removes excesssample from said distal portion of said sampling rod and leaves ametered sample in said metering ridges.
 10. The device of claim 1wherein said penetrable seal is made from a foil.
 11. The device ofclaim 1 wherein said penetrable seal is configured to hold a pressure of30 psi when said device is internally pressurized with air.
 12. Thedevice of claim 10 wherein said foil has a thickness of approximately0.001 inches.
 13. The device of claim 1 wherein said penetrable sealcomprises a foil layer and a polyester layer.
 14. The device of claim 13wherein said foil layer is 0.001 inch thick and said polyester layer is0.005 inch thick.
 15. The device of claim 1 wherein said body furthercomprises a recessed sealing surface, wherein said penetrable seal isaffixed to said sealing surface.
 16. The device of claim 15, whereinsaid recessed sealing surface is recessed 0.125 inches with respect to adistal end of said body.
 17. The device of claim 1 further comprising aprotective cap adapted to fit on a distal end of said body, wherein saidcap covers said penetrable seal.
 18. The device of claim 1 wherein saidpenetrable seal is made from a material selected from the groupconsisting of paper, rubber, wax, and plastic.
 19. The device of claim1, wherein said body is made from a material selected from the groupconsisting of polypropylene, polyethylene, polystyrene, andpolytetrafluoroethylene.
 20. The device of claim 1 wherein said samplecollection chamber has a volume of approximately 1-5 milliliters. 21.The device of claim 1 wherein said at least one metering ridge retains asample of approximately 20 milligrams of a fecal sample.
 22. The deviceof claim 1 wherein when said sampling rod is fully inserted through saidaperture in said septum, at least one metering ridge remains in contactwith said solution regardless of the orientation of the device.
 23. Thedevice of claim 1 wherein said solution has a volume of approximately 2milliliters.
 24. The device of claim 1, wherein said solution is a fecalsample solution comprising approximately 20 mM Tris (pH 7.4), 10% bovineserum albumen, 0.10% Tween-20, 0.095% sodium azide, 140 mM sodiumchloride, 10 mM EDTA, and 15 μg/ml gentamicin.
 25. A system forcollecting a sample, the system comprising: a) a sample collectionchamber holding a solution comprising components for preserving asuspended sample; b) a penetrable seal for sealing said chamber on anend, and configured to allow access to said chamber by penetrating saidpenetrable seal with a pipette tip or needle; b) a flexible sampling rodfor contacting a sample and acquiring a portion of said sample, saidflexible sampling rod comprising an asymmetrical beveled tip having anapex at the circumference of the flexible sampling rod and configured tobend the flexible sampling rod away from collisions and/or to deflectcollisions with an inserted pipette tip or needle c) a plurality ofmetering ridges for providing into said chamber a defined volume of saidacquired portion of the sample.
 26. The system of claim 25, wherein saidsolution comprises Tris buffer, bovine serum albumen, polysorbate 20,sodium azide, sodium chloride, ethylenediaminetetraacetic acid, andgentamicin.
 27. The system of claim 26, wherein said solution is a fecalsample solution that comprises approximately 20 mM Tris (pH 7.4), 10%bovine serum albumen, 0.10% polysorbate 20, 0.095% sodium azide, 140 mMsodium chloride, 10 mM ethylenediaminetetraacetic acid, and 15 μg/mlgentamicin.
 28. A kit for collecting a sample, the kit comprising: a)the device of claim 1; and b) an instruction for use.
 29. The kit ofclaim 28 further comprising a package in which to mail said devicecontaining a collected sample.